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Rapid disintegration tablet comprising a labile active ingredient in acid medium
专利权人:
NYCOMED GMBH
发明人:
DIETRICH, RANGO,LINDER, RUDOLF,NEY, HARTMUT
申请号:
ES01999360
公开号:
ES2380654T3
申请日:
2001.12.06
申请国别(地区):
ES
年份:
2012
代理人:
摘要:
A rapidly disintegrating tablet for oral administration of a labile active ingredient in acidic medium comprising a plurality of individual units of active ingredient together with one or more pharmaceutical excipients, wherein the individual units of active ingredient are microspheres and wherein the compound labile active acid medium is selected from the group consisting of an inhibitor of labile proton pumps in acid medium, a salt of an inhibitor of labile proton pumps in acid medium with a base and a hydrate of a salt of an inhibitor of labile proton pumps in acidic medium with a base, and is present in the individual units of active ingredient in a matrix composed of a mixture comprising at least one solid paraffin and one or more substances of the fatty alcohol, triglyceride and ester group of fatty acid, and where excipients are present which, in oral ingestion of the tablet, produce desi Rapid integration of the tablet, excipients comprising a mixture of at least one load, a disintegrant and a lubricant and wherein the tablet disintegrates in approximately 60 seconds or less when the tablet is subjected to a disintegration test as described in the European Pharmacopoeia (3rd edition, 1997), 2.9.1 disintegration time of tablets and capsules, where the disintegrant is selected from the group of insoluble polyvinylpyrrolidone, sodium carboxymethyl starch, sodium carboxymethyl cellulose, alginic acid and starches capable of carrying out the function of a disintegrantUna tableta que se desintegra rápidamente para administración oral de un ingrediente activo lábil en medio ácido que comprende una pluralidad de unidades individuales de ingrediente activo junto con uno o más excipientes farmacéuticos, en donde las unidades individuales de ingrediente activo son microesferas y en donde el compuesto activo lábil en medio ácido se selecciona del grupo constituido por un inhibidor de las bombas de protones lábil en medio ácido, una sal de un inhibidor de las bombas de p
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